MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. CAUTERY HIGH TEMP 2IN EXT SHAFT LOOP TIP; DISPOSABLE CAUTERY

Model Number	AA05
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.The complaint was able to be confirmed based on images provided from the customer.The root cause is determined to be a fit issue with the plastic tubes, where they were able to move down to the activation tip and prevent activation.Root cause is manufacturing error.This should be considered the final report.If any additional relevant information is identified it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "we would like to inform you of a non-compliance issue encountered on (b)(6) 2025, for one of our customers concerning one of your products.The reported anomaly is as follows: thermocutter malfunction observed on three devices used successively from the same batch.".

• Brand Name: CAUTERY HIGH TEMP 2IN EXT SHAFT LOOP TIP
• Common Device Name: DISPOSABLE CAUTERY
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 24260814
• Report Number: 3002750084-2026-00005
• Device Sequence Number: 7975783
• Product Code: HQP
• UDI-Device Identifier: 00607151011055
• UDI-Public: 00607151011055
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K121441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AA05
• Device Lot Number: 0323U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown